Institutional members access full text with Ovid®

Share this article on:

A Randomized, Placebo-Controlled Trial to Assess the Safety and Acceptability of Use of Carraguard Vaginal Gel by Heterosexual Couples in Thailand

KILMARX, PETER H. MD*†; BLANCHARD, KELLY MSc; CHAIKUMMAO, SUPAPORN BHP; FRIEDLAND, BARBARA A. BA; SRIVIROJANA, NUCHAREE MSc§; CONNOLLY, CATHY MPH; WITWATWONGWANA, PAISIT MD; SUPAWITKUL, SOMSAK MD**; MOCK, PHILIP A. MAppStats; CHAOWANACHAN, THANYANAN MSc; TAPPERO, JORDAN MD*†

Sexually Transmitted Diseases: March 2008 - Volume 35 - Issue 3 - p 226-232
doi: 10.1097/OLQ.0b013e31815d6e0d
Article

Objectives: To determine the safety and acceptability of use of Carraguard, a carrageenan-derived candidate microbicide gel, during sexual intercourse in women and men.

Study Design: We conducted a 6-month randomized, placebo-controlled trial among sexually active, couples at relatively lower risk for HIV infection in northern Thailand.

Methods: Women inserted 1 applicator of study gel vaginally every time the couple had sex. Safety was assessed by symptom report and genital examination of both partners and by changes in vaginal flora. Acceptability was assessed by participant interview.

Results: Overall, 55 couples were randomized, 28 to Carraguard use and 27 to the methyl-cellulose placebo gel group. Retention and study gel use were similarly high in both study groups; use of gel without condoms was reported in more than 95% of vaginal sex acts. The 2 study groups were similar in the proportions of women and men with symptoms or with genital findings without epithelial disruption, of men with findings with epithelial disruption, and of women with abnormal genital flora, whereas more women in the placebo group had findings with epithelial disruption. Women and men in both groups reported that the gel and applicator were acceptable.

Conclusions: Carraguard can safely be used an average of 2 to 3 times per week during sex and is acceptable to Thai women and men.

Use of Carraguard, a carrageenan-derived candidate microbicide gel, during sexual intercourse was found to be safe and acceptable to Thai men and women.

From the *National Center for HIV, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta; †Thailand Ministry of Public Health – U.S. Centers for Disease Control and Prevention Collaboration, Bangkok, Thailand; ‡Population Council, New York; §Population Council, Bangkok, Thailand; ∥Medical Research Council of South Africa, Durban, South Africa; ¶Chiang Rai Hospital, and **Chiang Rai Public Health Office, Chiang Rai, Thailand.

We thank Cheng Chen, Chris Elias, Charlotte Ellertson, Philip Guest, Heidi Jones, Robin Maguire, Timothy Mastro, Janneke van de Wijgert, Beverly Winikoff, the staff of the Thailand MOPH-US CDC Collaboration Laboratory, Data Management, and Administration Sections, the Chiang Rai Health Club, Chiang Rai Public Health Office, Chiang Rai Hospital, and Population Council offices in Bangkok and New York.

Financial support for this study was provided by the US Centers for Disease Control and Prevention (CDC) and the Bill and Melinda Gates Foundation.

Correspondence: Peter H. Kilmarx, MD, Division of HIV/AIDS Prevention, CDC/Atlanta, 1600 Clifton Road, MS E-45, Atlanta, GA 30333. E-mail: pbk4@cdc.gov.

None of the authors has a commercial association with Carraguard nor other conflicts of interest. Carraguard is being developed by the Population Council, which is a not-for-profit nongovernmental organization, under a US Food and Drug Administration Investigational New Drug Application (IND 58,441).

The findings and conclusions in this article are those of the authors and do not necessarily represent the views of the CDC.

Received for publication March 1, 2007, and accepted September 9, 2007.

© Copyright 2008 American Sexually Transmitted Diseases Association